The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) Images Interpretation in Gastric Intestinal Metaplasia (GIM)

The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) Images Interpretation in Gastric Intestinal Metaplasia(GIM)

The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) images interpretation in Gastric Intestinal Metaplasia (GIM)

Objective:

The aim of this study is to evaluate the learning curve of pCLE images interpretation in GIM.

Research design:

Blinded review of pCLE images for the diagnosis of GIM

Sample size:

Five beginner endoscopists will be assigned in this study to read approximately 80 videoclips

Data analysis:

ROC curve is analyzed by SPSS version 16.

Expected Benefit and Clinical Application Information on the learning curve for GIM interpretation from pCLE images in order to develop early gastric cancer detection

Study Overview

• Status: Unknown
• Conditions: Gastric Intestinal Metaplasia

Detailed Description

Background and Rationale:

Gastric cancer remains the second leading cause of cancer related death in the world. The incidence and mortality rate is predominant in East Asia[1]. Usually, gastric cancer is asymptomatic in early stage; therefore, most patients are in the advanced stage and incurable at diagnosis. The pathogenesis of intestinal type gastric cancer is sequential and multistep pathway. Gastric intestinal metaplasia (GIM) is the precancerous lesion for intestinal type gastric cancer[2]. The strategies which can detect precancerous and/or early cancerous transformation are very beneficial because only early gastric cancer can potentially be cured by endoscopic treatment. Probe-based confocal laser endomicroscope or pCLE is useful for GIM detection with 94% in sensitivity[3]. However, this perfect sensitivity in pCLE interpretation is provided in only expertise. We still do not know how to be an expert in GIM interpretation. No study about learning curve in GIM interpretation by pCLE published

Observation and Measurement:

Collect the accuracy in GIM interpretation from pCLE reported in ROC curve

Methodology:

1. Six inexperienced pCLE readers were recruited.
2. All inexperienced pCLE readers must attend the learning session.
3. Self-review from CD is recommended for all inexperienced pCLE readers
4. Two-week interval for examination in GIM interpretation from 20 new histology-proved pCLE images (GIM and normal mucosa) for 5 sessions are on schedule after training session.
5. All Inexperienced pCLE readers need to review the training CD at least a day before each examination.
6. The accuracy rate in each examination will be recorded individually for each inexperienced pCLE reader.
7. ROC curve is reported for learning curve in GIM interpretation from pCLE images.

Data collection:

All data will be processed and recorded by one physician.

• Study Type: Observational
• Enrollment (Anticipated): 5

Contacts and Locations

• Study Contact: Name: Rapat Pittayanon, MD; Phone Number: 66813132112; Email: rapat125@gmail.com
• Study Contact Backup: Name: Nuttaphat Namjud, M.Sc.; Phone Number: 66894971957; Email: ampere_nut@hotmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Recruiting
    • Rapat Pittayanon
    • Contact: Rapat Pittayanon, MD; Phone Number: 66813132112; Email: rapat125@gmail.com
    • Contact: Nuttapaht Namjud, M.Sc; Phone Number: 66894971957; Email: ampere_nut@hotmail.com
    • Sub-Investigator: Rungsun Rerknimitr, Professor
    • Principal Investigator: Rapat Pittayanon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

5 beginner endoscopists who never had the experience in pCLE

Description

Inclusion Criteria:

• First year fellow of gastroenterologist who never have the experienced in pCLE interpretation.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
pCLE images

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of accuracy of pCLE images interpretation in GIM after each examination	Percentage of accuracy changing in each examination	Baseline and every 2 weeks for 4 sessions

Collaborators and Investigators

• Sponsor: King Chulalongkorn Memorial Hospital
• Investigators: Study Director: Rungsun Rerknimitr, Professor, King Chulalongkorn Memorial Hospital; Principal Investigator: Rapat Pittayanon, MD, King Chulalongkron Memorial Hospital

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): January 1, 2012
• Study Completion (Anticipated): April 1, 2012

Study Registration Dates

• First Submitted: December 5, 2011
• First Submitted That Met QC Criteria: December 12, 2011
• First Posted (Estimate): December 14, 2011

Study Record Updates

• Last Update Posted (Estimate): December 15, 2011
• Last Update Submitted That Met QC Criteria: December 14, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metaplasia
• Other Study ID Numbers: RP001